study to investigate the safety, tolerability, steady state pharmacokinetic and pharmacodynamic profile of bia 3-202

Conditions: Parkinson's Disease

Summary: the objectives as stated in the study protocol were as follows: * to investigate the safety and tolerability of three multiple dose regimens of bia 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). part a * to characterise the steady state pharmacokinetic and pharmacodynamic profile of bia 3-202 in healthy young males. part a * to investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from part a) of bia 3-202, in healthy elderly volunteers. part b * to characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from part a) of bia 3- 202 in healthy elderly volunteers. part b

this was designed as a single centre, phase i, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (part a) and a single group of healthy elderly volunteers (part b). in part b, 12 healthy elderly volunteers were to be enrolled. ten were to be randomly allocated to bia 3-202 and two to placebo.

Eligibility criteria:
inclusion criteria: * adult males aged 18-35 years, with a body mass index (bmi) of 19-28 kg/m2. * subjects who were healthy as determined by pre-study medical history, physical examination and 12-lead ecg. * subjects who had clinical laboratory tests acceptable to the investigator. * subjects who were negative for hbsag, anti-hcv and hiv i and ii tests at screening. * subjects who were negative for drugs of abuse and alcohol tests at screening and admission. * subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day. * subjects who were able and willing to give written informed consent. exclusion criteria: * subjects who did not conform to the above inclusion criteria. * subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant atopy. * subjects who had a history of relevant drug hypersensitivity. * subjects who had a history of alcoholism. * subjects who had a history of drug abuse. * subjects who consumed more than 28 units of alcohol a week. * subjects who had a significant infection or known inflammatory process on screening and/or admission. * subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn). * subjects who had an acute infection such as influenza at the time of screening and/or admission. * subjects who had used prescription drugs within 4 weeks of first dosing. * subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of first dosing. * subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study. * subjects who had previously received bia 3-202. * subjects who had donated and/or received any blood or blood products within 3 months prior to screening. * subjects who were vegetarians, vegans and/or had medical dietary restrictions. * subjects who could not communicate reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent.

Keywords: parkinson's disease nebicapone